From EnvisionTEC’s FDA approval to InVivo Therapeutics adding a new clinical site, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EnvisionTEC wins FDA nod for 3D printing E-Denture material EnvisionTEC announced in a June 30 press release that it has received FDA approval for its E-Denture material […]
Medtech stories we missed this week: June 30, 2017
From ConforMIS touting its knee replacement study to Consulting Radiologists’s new breast cancer detection tool, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Study: Low-dose CT scanning improves Ankylosing Spondylitis assessment A new study has shown that low-dose computed tomography (LD-CT) is more sensitive than X-rays for monitoring […]
FDA user fee reauthorization advances without $1B fee increase
By Stewart Eisenhart, Emergo Group The US Senate’s version of a bill reauthorizing Food and Drug Administration user fees over the next several years diverges markedly from President Trump’s budget proposal to increase user fees by $1 billion in 2018 alone. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA guidance explains electronic records for medical device clinical trials
By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
West Pharmaceutical Services touts needle shield
West Pharmaceutical Services has expanded its product offerings to include the Rigid Needle Shield (RNS). The RNS helps add safety to profiled syringes with a staked needle. It also helps ensure the integrity of injectable drug products. “Pharmaceutical companies continue to look for drug packaging and delivery solutions that offer safety, efficiency and an improved […]
FDA commissioner proposes new program for digital health product regulations
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to roll out a new program for mobile medical apps and related digital health products in order to clarify the agency’s regulatory scope regarding these technologies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Medtech stories we missed this week: June 23, 2017
From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for […]
Brazilian medical device regulators change registration submission formats
By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
FDA Science: Working at the speed of emerging technologies
By Luciana Borio, M.D. Let’s face it, we’ve all gotten used to nearly instant access to almost anything. Today, with a tap of an app, we order a car ride, a book, or pizza for dinner. Need to navigate past traffic in downtown city streets? No problem. There’s an app for that, too. Some may […]
5 secrets of contract manufacturing longevity
Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value. We asked top executives from long-lasting medical device industry suppliers to share their secrets. Mike Ondercin started Cleveland-based Criterion as […]